Drug Development: This course studies the drug development process from discovery through FDA marketing approval. It reviews the process of development and the interrelationships linking the various disciplines, introducing students to regulations governi
- Hyderabad, India
- Program Type:
- Study Abroad
- Degree Level:
- Academic Year, Fall Semester
- Program Description:
- Clinical Trial Management – This 5-course certificate program is designed for pharmaceutical and healthcare professionals who are interested or already participate in all aspects of clinical trials. It provides the tools and information needed to design, conduct and audit clinical trials of pharmaceuticals. The courses emphasize protocol development, volunteer informed consent, study management, and the role and responsibilities of Institutional Review Boards.
Drug Development: This course studies the drug development process from discovery through FDA marketing approval. It reviews the process of development and the interrelationships linking the various disciplines, introducing students to regulations governing the process, including the interactions with FDA, ICH, and other regulatory agencies. Clinical Drug Safety and Pharmacovigilance: This course provides students with an in-depth understanding of what pre-marketing Clinical Safety and Risk Management (CSRM) means in the context of both American (FDA) and international (ICH-E2C) regulatory requirements. Beginning with an historical overview of IND and international safety requirements, it examines the processes and systems in place to support compliance and the strategic documentation required for applications. It also looks at the role of risk management and epidemiological methods used to identify the signals used to quantify, assess, and communicate adverse drug reactions (ADR). Topics include clinical trial policy, the roles of the investigator, patient, and IRBs, privacy issues, informed consent, DSMB, and other related matters. Legal and Regulatory Basis of Pharmacovigilance: This course provides students with a basic understanding of the key regulations and laws that influence the development and management of a pharmacovigilance system, either in a manufacturer or health agency environments. The main emphasis will be on FDA, EU, and Japan and ICH, but discussions of emerging countries’ systems will also be included. In addition to pharmaceuticals, the course provides an overview of the related product vigilance areas, such as medical devices, over-the-counter products, and drug/device combinations. In addition to understanding the regulatory framework, additional instruction will include discussions of partnership agreements, pharmacovigilance aspects of due diligence, licensing and acquisitions, and product liability issues. Good Clinical Practices: This course examines the federal regulatory requirements and processes necessary to conduct valid drug trials on human volunteers. Emphasis is placed on managing the clinical drug study and auditing its processes and generated data. The course also addresses ethical issues and volunteer informed consent. Bioethics for Pharmaceutical Professionals: This course focuses on bioethical issues arising in the regulation and conduct of research. It instills a basic understanding of bioethics and the theories and principles underlying its practices and application to research. It also discusses how bioethical theories and principles provide the foundation for many research regulations. Starting with a brief history of research ethics and regulation, it explores past and present ethical research controversies.
1. Temple University was the first institution of higher learning to develop a master’s program in Quality Assurance and Regulatory Affairs in 1968. This is their first launch in India. 2. Most comprehensive academic curriculum of its kind, featuring advanced courses in the quality principles and regulatory issues affecting today’s pharmaceutical industry. 3. Experts from industry and US Food and Drug Administration (FDA) teach the classes 4. Opportunity for career enhancement for industry professionals and join the fastest growing segment within the clinical research support services industry 5. All courses are accredited and transferred towards the Masters/Graduate Program in Quality Assurance and Regulatory Assurance Program at Temple University’s School of Pharmacy. 6. Opportunity to join the Master program in Temple University in USA directly or after completing 15 credits in India at 50% of the cost 7. Live Video conference classes from Temple University in Philadelphia, PA USA Temple’s QA/RA graduate program also offers remote delivery of courses directly to IDDCR via videoconferencing.
- Setting Description:
- 1.A postgraduate or graduate in Bachelors of Science, Masters in Science, MBBS or BDS including Medicine, Pharmacy, Nursing, Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotech) 2. Graduated with minimum 60 percent 3. TOEFEL score: 585 paper based exam, 230 for computer based or 85 for online exam
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